In my career I’ve spent many years consulting for the American Red Cross, which is a great organization to work for if you want to feel that everything you do on daily basis counts for something in your fellow Americans’ real lives. I worked as a senior engineer for a few months, several years as a team lead, and then several more as a chief systems architect on the National Biomedical Computer System (NBCS), which is one of the world’s largest FDA-relgulated 510k medical devices. NBCS manages the blood collection and distribution workflow for Red Cross’ blood donation program. The entire hardware, software, and communications infrastructure which included millions of lines of code and dozens of servers is covered under the 510k. When I saw this “Judge Rules Against FDA in Landmark Medical Device Manufacturing Case” press release come across my desk it brought back memories of the kind of struggles we went through trying to get and maintain FDA approval on the projects I worked on. The following quote from the release is especially familiar:

This is a landmark decision that clearly shows that medical device companies need to comply with the relevant regulations, not the subjective demands of FDA personnel,” said McKenna Long & Aldridge attorney Dan Jarcho. “This ruling is a common sense breath of fresh air that affirms that regulated companies can turn to the courts when the FDA refuses to act fairly.”

The 510k submission process, while covered under CFR, is indeed quite subjective (especiallyfor something as complex as a software device). This ruling against the FDA will probably the first of many cases where small and large device manufacturers will be able to question FDA personnel, which may or may not be a good.

Another interesting snippet of the PR is the following

At issue was a disagreement over how the company sought to meet QSR requirements in the areas of adequately validating its manufacturing process, validating its software and uniform complaint handling process. In August 2004 the FDA sought to shut down the operation of Utah Medical’s 160-person facility in Midvale, Utah.

Keep in mind that FDA can, and sometimes does, shut down operations of a facility for lack of paperwork and other subjective reasons, regardless of whether or not there is actual evidence of any flaw in the device. This action keeps manufacturers diligent with respect to paperwork, sometimes costing significant amounts of time and money, which may take away time from actual engineering and validation concerns.

Another interesting aspect of the article is on the word ‘nitpicking’, something which almost all manufacturers can sympathize with (imagine showing a unit test result or formal code review document to a legal or government official who knows nothing about coding).

…the FDA’s case, which he characterized as “extended and in some instances ‘nitpicking,’” arose “in part because of the general nature of the regulations themselves, which have the virtue of generality and the vice of imprecision. This endemic problem is perhaps augmented by decision-makers who themselves rely too much on inspectors’ reports without taking a fresh look themselves at ongoing changes made by Utah Medical in response to questions raised.”

As a veteran working on a complex system that took years to gain and maintain a 510k medical device status, I am a bit torn by the ruling. I think that it’s good that subjective ‘nitpicking’ can now be questioned but it’s also going to weaken the FDA a bit to where they may not be able to do their job properly unless they are able to have substantive say in how a medical device is validated. Only time will tell what this case means but if a small company like Utah Medical Products can beat the FDA, the precedent can sure be used by larger firms with more resources. Now, instead of spending time fighting FDA on the grounds that validation practices, test plans, and devices are sound medical devices the courts may accidentally become a way for vendors to get around strict rules and regs.

If you’re interested in the case, the full legal opinion is available.